K252597
- 510(k) number
- K252597
- Device name
- Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-19
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252597.pdf
Official FDA record: K252597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.